FDA UDI
In Commercial Distribution
🇺🇸 United States
Atellica IM PSA MCM
DI: 00630414599823
·
Model: 10995664
·
Siemens Healthcare Diagnostics Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Atellica IM PSA MCM
- Primary DI
- 00630414599823
- Version / Model
- 10995664
- Catalog Number
- 10995664
- Company Name
- Siemens Healthcare Diagnostics Inc.
- Labeler DUNS
- 064608573
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2018-11-14
- Public Version
- 6
- Public Version Date
- 2021-11-18
- Public Version Status
- Update
- Public Device Record Key
- 2d895b50-ddcf-4687-a0ff-601c54b9da08
Device Description
Prostate Specific Antigen (PSA) - Atellica IM - Master Curve Material Kit 9 x 1 x 1.0mL
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LTJ | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS | Immunology | 866.6010 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38207 | Total prostate specific antigen (tPSA) IVD, control | A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00630414599823 | GS1 |
Customer Contacts
- Phone
- +1(877)229-3711
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| P950021 | 015 |
| P950021 | 016 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Store Upright, Do not freeze, Resuspend.
- Type
- Storage Environment Temperature
- Temperature Range
- 2 – 8 Degrees Celsius